# K983169: Polymer Threaded Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Biosystems, Ltd.
- Decided: Dec 16, 1998 after 97 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963402 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972326: Peba Anchor/Suture Combination, Orthopaedic Biosystems, Ltd. (1998) Summary page 1.
- K963402: Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener, Innovasive Devices, Inc. (1996) Summary page 1.

## Indications for use
This device (Polymer Threaded Anchor and Cinch Polymer Threaded Anchor) is intended for use only for the fixation of non-absorbable synthetic sutures. The Polymer Threaded Anchor is intended for the fixation of surgical suture material for the following indications: Shoulder: Bankart lesion repairs SLAP lesion repairs Acromio-clavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs Foot and Ankle: Hallux Valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions 1bow Wrist, and Hand: Scapholunate ligament reconstructions Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment Knee: 1. Extra-capsular repairs: a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament 2. Hiotibial band tenodesis 3. Pateliar realignment and tendon repairs, including vastus medialis oblivious advancement The Cinch Polymer Threaded Anchor is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K983169
Methodology: https://510kreport.com/methodology